Tuesday, December 16, 2008

CME Teleseminar Q&A (Part I)

Below are the answers to some questions we received after the December 4th teleseminar, "What Every Medical Writer Should Know About Developing Continuing Medical Education (CME) Materials."

“How do you think the newest Pharma guidelines and CME guidelines will impact the CME market?”

This is the question that has been asked by all stakeholders over the past year and there continues to be a lot of speculation in the industry on what final impact the new guidelines will have on the CME market. There is no doubt in anyone’s mind that CME is here to stay. The question is how will CME be funded.

Some proponents feel that commercial support should be eliminated from CME altogether. Some state physicians should pay more for CME credit, eliminating the need for commercial funding. Others believe there should be a central pot into which Pharma deposits grant monies which could then be distributed for CME by an independent entity.

At this time there is no consensus and Pharma continues to fund CME.

“Since Pharma can no longer even suggest a topic for CME, do you think they will stop funding these programs?”

I believe that Pharma will keep funding CME unless a law or regulation is passed prohibiting their sponsorship. Although there is a lot of discussion about the role commercial support should play in CME, at this time there are no laws preventing Pharma from continuing to sponsor CME.

Pharma’s motivation has always been to bring their products to the attention of physicians and to make sure physicians understand their use. Sponsorship has been an important marketing strategy for them.

It is important to note that the Accrediting Council for Continuing Medical Education (ACCME) has always maintained that there be a ‘firewall’ between the commercial supporters of CME and the actual educational content of CME. So, the edict that Pharma should not to be allowed to suggest topics for CME is nothing new.

How this could affect CME medical writers? As long as CME is required for re- licensure, there will be work for CME medical writers. Whether or not commercial funding is allowed or not is primarily a funding issue. Even if commercial support is eliminated from CME altogether,CME must still be created.

"I work with medical and scientific information daily, however, I do not hold an advanced degree in the sciences or English and generally find that I have the knowledge to understand basic concepts and then need to research details. In your opinion, would I have sufficient background and knowledge at this stage to successfully create CME-related products?"

Most medical writers do have an advanced degree in some science or health related field. Some also specialize in particular health areas, such as cardiology or neurology, etc. However, many writers have a strong foundation in biology or human physiology and are generalists. Whether specialists or generalists, most writers have to do some amount of research on topics they write about and have to know the rules and regulations pertaining to CME.

A basic grounding in biology and human physiology is adequate to create CME. CME differs from scientific medical writing in that often one is hired to prepare documents related to the content but the content is created by someone else. For example, I was hired to write a required report called a Needs Assessment which summarized current literature validating the need for a CME program on a specific medical topic. The program content, however, was written by others with more expertise in the program topic.

There are three qualifications clients review when choosing a medical writer to create any CME-related product.

Education – advanced degrees

Training - instruction in medical writing in general and CME in particular

Experience – a history of creating CME and/or CME related projects, i.e. a portfolio and roster of past clients

In your case, you have an advanced degree in Medical and Biological Illustration – a master’s that provided what sounds like a basic foundation in physiology and biology. This could satisfy your education qualification. What you are lacking is the training in CME and the experience.

I believe my course could give you the training in CME you need. You will get instruction in CME with a focus on what medical writers need to know.

As far as experience goes, you may be interested to learn that I am in the process of creating an internship program for medical writers which places them, either on site or virtually, with medical education companies. It is my hope to provide writers who are trying to break into the CME field with real experience from which they can learn and that they can note on their resumes along with testimonials they might receive for their work. I hope to launch this program in early 2009. I am also in discussion with other parties about creating a freelance company where graduates of my training can be listed along with their three types of qualification. (It has not yet been decided if the internship program and listing opportunity will be available to all participants or just graduates of the advanced coaching program.)

In summary - yes, I believe if you get some additional training in CME and acquire some relevant experience, you could get work as a freelancer or as an employee.